Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis

NCT07091344 | Recruiting

• 1 other identifier: PS-01-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the relationship between cognitive, metacognitive and social cognition variables in patients with psychosis undergoing VR-based Avatar Therapy for the treatment of auditory hallucinations. In addition to the primary intervention, participants will be assessed using validated tools for emotion recognition, attributional style, theory of mind, neurocognition, and metacognition. The study also explores the potential role of trauma as a predisposing factor. Assessments will be conducted at four time points: screening (week 0), baseline (week 12), intervention period (weeks 12-24), and post-therapy follow-up (week 24). By investigating these variables, this study seeks to better understand their impact on treatment outcomes and contribute to the development of personalized therapeutic approaches.

Conditions

Schizophrenia Disorders; Treatment Resistant Hallucinations

Keywords

VR-based Avatar Therapy; cognition; metacognition; social cognition; psychosis; schizophrenia spectrum disorders; auditory hallucinations; trauma and psychosis; emotion recognition; Personalized therapy

Outcome Measures

Primary Outcomes (8)

• Change in Emotion Recognition Score

  Change in participants' ability to recognize basic emotions using the Faces Test. Score range: 0-20; higher scores = better emotion recognition.

  Week 0, Week 12, Week 24

• Change in Executive Functioning Score

  Change in Executive Functioning Score Executive functioning assessed with the Wisconsin Card Sorting Test (WCST). Outcomes include number of categories completed (0-6; higher = better) and number of perseverative errors (no fixed maximum; lower = better). The task ends when the participant completes 6 categories or after all 128 cards are placed.

  Week 0, Week 12, Week 24.

• Change in Attributional Style Score

  Attributional style in ambiguous social situations assessed with the Ambiguous Intentions Hostility Questionnaire (AIHQ). Score range: 0-100; higher scores = greater hostile attribution/conviction.

  Week 0, Week 12, Week 24

• Change in Theory of Mind Score

  Ability to infer others' intentions measured by the Hinting Task. Score range: 0-6; higher scores = better Theory of Mind.

  Week 0, Week 12, Week 24

• Change in Metacognition Score

  Cognitive insight measured by the Beck Cognitive Insight Scale (BCIS): Self-reflectiveness (0-27; higher = better) and Self-certainty (0-21; higher = worse).

  Week 0, Week 12, Week 24

• Change in Cognitive Flexibility Score

  Mental flexibility assessed with the Trail Making Test, Part B. Outcome: time in seconds (maximum 300 seconds); lower times = better performance.

  Week 0, Week 12, Week 24

• Change in Global Cognitive Performance Score

  Global cognition assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). Total score range: 0-75; higher = better cognitive performance.

  Week 0, Week 12, Week 24

• Change in Working Memory Score

  Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance.

  Week 0, Week 12, Week 24

Other Outcomes (2)

• Childhood Trauma Exposure (Baseline moderator)

  Week 0 (one-time measure).

• Change in Verbal Skills Score

  Week 0, Week 12, Week 24

Study Arms (1)

VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

EXPERIMENTAL

Participants will receive VR-based Avatar Therapy over a 12-week intervention period, consisting of 7 individual therapy sessions. This intervention is designed to externalize and reframe distressing auditory hallucinations using virtual reality. In addition to the standard therapy, participants will undergo comprehensive assessments of cognition, metacognition, and social cognition at screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24). These measures will evaluate emotional recognition, attributional style, theory of mind, cognitive flexibility, and trauma history, aiming to explore their role in treatment outcomes.

Behavioral: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

Interventions

VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments BEHAVIORAL

VR-Based Avatar Therapy is a 12-week intervention designed to help patients with psychosis manage distressing auditory hallucinations. The therapy consists of 7 individual sessions using virtual reality (VR) technology to externalize the auditory hallucinations, allowing patients to interact with a computer-generated avatar representing their dominant voice. In addition to standard therapy, participants will undergo assessments of cognition, metacognition, and social cognition to explore their impact on treatment outcomes. These assessments include measures of emotion recognition, attributional style, theory of mind, cognitive flexibility, and trauma history. Sessions are conducted using VR headsets and noise-canceling headphones to enhance immersion, and patients receive ongoing therapeutic guidance throughout the process.

VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria.
• Experience of persistent auditory hallucinations for at least 3 months (PANSS hallucination score ≥ 3).
• Stable medication dosage for at least 4 weeks prior to recruitment.
• Fluent in the spoken language of the study site (Spanish).
• Able to provide informed consent.
• Regular psychiatric follow-up care.

You may not qualify if:

• Inability to identify a dominant voice for Avatar Therapy intervention.
• Intellectual disability based on medical history.
• Active substance abuse.
• Central nervous system injury or neurological disorders affecting cognitive performance.
• Severe visual impairment that precludes the use of VR technology.
• Aversion to virtual reality or prior experience of simulator sickness.
• Current suicidal ideation or risk.
• Lack of cooperation or inability to comply with study procedures.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu

Barcelona, Catalonia, 08950, Spain

RECRUITING

Related Publications (11)

• Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.

  PMID: 8541250 BACKGROUND

• Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

  PMID: 12615092 BACKGROUND

• Schmid P, Czekaj A, Frick J, Steinert T, Purdon SE, Uhlmann C. The screen for cognitive impairment in psychiatry (SCIP) as a routinely applied screening tool: pathology of acute psychiatric inpatients and cluster analysis. BMC Psychiatry. 2021 Oct 9;21(1):494. doi: 10.1186/s12888-021-03508-4.

  PMID: 34627191 BACKGROUND

• Reitan RM. Trail making test results for normal and brain-damaged children. Percept Mot Skills. 1971 Oct;33(2):575-81. doi: 10.2466/pms.1971.33.2.575. No abstract available.

  PMID: 5124116 BACKGROUND

• Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0.

  PMID: 15099613 BACKGROUND

• Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.

  PMID: 17453895 BACKGROUND

• Brebion G, Stephan-Otto C, Cuevas-Esteban J, Usall J, Ochoa S. Impaired memory for temporal context in schizophrenia patients with hallucinations and thought disorganisation. Schizophr Res. 2020 Jun;220:225-231. doi: 10.1016/j.schres.2020.03.014. Epub 2020 Mar 24.

  PMID: 32220501 BACKGROUND

• Lorente-Rovira E, Grasa E, Ochoa S, Corripio I, Pelaez T, Lopez-Carrilero R, Gutierrez-Gea A, Morano-Guillen M, Villagran JM, Bartels-Velthuis AA, Jenner JA, Sanjuan J. Different measures for auditory hallucinations in populations with psychosis. The Validation of the Spanish versions of the Auditory Vocal Hallucination Rating Scale (AVHRS) and the Positive and Useful Voices Inquiry (PUVI). Rev Psiquiatr Salud Ment (Engl Ed). 2022 Oct-Dec;15(4):259-271. doi: 10.1016/j.rpsmen.2020.03.002.

  PMID: 36513402 BACKGROUND

• Stephan-Otto C, Nunez C, Lombardini F, Cambra-Marti MR, Ochoa S, Senior C, Brebion G. Neurocognitive bases of self-monitoring of inner speech in hallucination prone individuals. Sci Rep. 2023 Apr 17;13(1):6251. doi: 10.1038/s41598-023-32042-4.

  PMID: 37069194 BACKGROUND

• Diaz-Cutraro L, Garcia-Mieres H, Dimaggio G, Lysaker P, Moritz S, Ochoa S. Metacognition in psychosis: What and how do we assess it? Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):206-207. doi: 10.1016/j.rpsm.2022.09.003. Epub 2022 Sep 24. No abstract available.

  PMID: 37716848 BACKGROUND

• Garety PA, Edwards CJ, Jafari H, Emsley R, Huckvale M, Rus-Calafell M, Fornells-Ambrojo M, Gumley A, Haddock G, Bucci S, McLeod HJ, McDonnell J, Clancy M, Fitzsimmons M, Ball H, Montague A, Xanidis N, Hardy A, Craig TKJ, Ward T. Digital AVATAR therapy for distressing voices in psychosis: the phase 2/3 AVATAR2 trial. Nat Med. 2024 Dec;30(12):3658-3668. doi: 10.1038/s41591-024-03252-8. Epub 2024 Oct 28.

  PMID: 39468363 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hallucinations; Wounds and Injuries

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Susana Ochoa, PhD

CONTACT

+34936406350; susana.ochoa@sjd.es

Luciana Díaz-Cutraro, PhD

CONTACT

+34936406350; luciana.diaz@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Research Unit Coordinator

Model Details: The study employs a single-group pre-post interventional design with a waiting list control phase. All participants will initially undergo a 12-week waiting period (control phase) starting at screening (week 0). Baseline assessments will be conducted at week 12, followed by a 12-week intervention phase where participants receive 7 individual VR-based Avatar Therapy sessions. Post-therapy assessments will be conducted at week 24 to evaluate changes in auditory hallucinations and associated cognitive, metacognitive, and social cognition variables. This design allows for a comprehensive evaluation of both the direct effects of the intervention and the potential moderating or mediating role of the measured variables on therapeutic outcomes.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: July 29, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anonymized IPD and supporting documents will be made available after publication of the main study results and for a minimum period of 5 years, starting approximately 12 months after study completion.
• Access Criteria: Qualified researchers affiliated with academic or healthcare institutions may request access to anonymized IPD and supporting documents for independent verification or secondary analysis. Requests will be reviewed by the sponsor and must include a data-sharing agreement and ethics approval. Access will be provided through a secure institutional platform.

Locations

ES (1)